Dexcom Inc. (NSDQ:DXCM) is reportedly launching upgrades for its G6 diabetes system and plans to launch its direct-to-Apple Watch version over the next year. The Apple and Dexcom collaboration would allow diabetes patients to track glucose through the Apple Watch, a consumer wearable, according to CNBC. Get the full story on our sister site, Drug Delivery Business […]
DHS warns again on cybersecurity flaw in BD Alaris workstations
The U.S. Homeland Security Dept. yesterday warned of two more cybersecurity vulnerabilities with the Alaris infusion pump made by Becton, Dickinson (NYSE:BDX). The DHS Industrial Control Systems Cyber Emergency Response Team, acting on weaknesses unearthed by researchers at CyberMDX, said the vulnerabilities could allow a malicious attacker to completely disable BD’s Alaris Gateway Workstation and install malware […]
Resonetics expands Medibrane investment
Resonetics (Nashua, N.H.) today announced that it is making an additional equity investment in and providing debt financing to Medibrane. The company took minority ownership of Israel-based Medibrane as part of its acquisition of STI Laser in November 2018. “Having worked with the founders at Medibrane for the past six months, we’ve grown increasingly excited […]
FDA clears CorMatrix Cardiovascular’s Cor heart tissue patch
CorMatrix Cardiovascular said it received FDA 510(k) clearance for its Cor Patch epicardial patch. The Cor Patch epicardial patch is designed to repair the atria and the left and right ventricular walls of the heart that are thin or damaged as a result of myocardial infarct. “We have a unique opportunity to enhance the repair […]
ReWalk Robotics raises $11m in warrants offering
ReWalk Robotics (NSDQ:RWLK) said yesterday that it raised $11 million in a warrants offering. Israel-based ReWalk Robotics sold roughly 1.5 million five-year warrants in November 2018 that are now being redeemed for $7.50 apiece, resulting in gross proceeds of $11 million and net proceeds of about $10 million. The warrants were issued on June 5-6, according […]
Nuvectra seeks another FDA nod for spinal cord stimulation system
Nuvectra said yesterday that it filed for expanded FDA approval of its Algovita spinal cord stimulation device. The Plano, Texas-based company asked the federal safety watchdog for full-body MR-conditional approval for the Algovita SCS. The device first received FDA premarket approval in 2015. “We believe full-body MR conditional approval in the U.S., in addition to Algovita’s […]
ADA 2019: Hybrid closed-loop devices take center stage
The American Diabetes Association’s 79th Scientific Sessions is a five-day conference where researchers and healthcare professionals share the latest in diabetes research. More than 180 sessions and over 2,000 research presentations took place during the meeting on June 7-11 in San Francisco. During the meeting, diabetes experts shared data and research from clinical trials. Here are four […]
Baxter launches telehealth service for home dialysis treatments
Baxter (NYSE:BAX) today announced that it has launched its Sharesource 2.0 telehealth clinical portal. Sharesource is a telehealth platform for home dialysis the helps healthcare providers get better insight into a patient’s home peritoneal dialysis (PD) treatments. The system has helped manage more than 7 million PD treatments in more than 40 countries, according to the […]
Human factors and usability investment considerations for medtech companies
By Mark Tavano, Emergo Group Embedding human factors engineering (HFE) and usability studies early in medical device design and development cycles can yield benefits beyond regulatory compliance for manufacturers. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the author’s only and do not necessarily reflect […]
Chinese authorities update regulatory guidelines
By Stewart Eisenhart, Emergo Group China’s National Medical Product Administration (NMPA) has clarified various technical review and information guidelines related to medical device registration and approval. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of MassDevice.com […]
Plaintiffs appeal Ocular Therapeutix win in shareholder lawsuit
Ocular Therapeutix (NSDQ:OCUL) is facing a revived class-action lawsuit lodged by investors after its share price took a hit after it revealed problems with its Dextenza device. The lawsuit, filed in the U.S. District Court for Massachusetts in November 2017, alleged that the Bedford, Mass.-based company misled shareholders about problems found by FDA inspections in 2017 that sent […]